Archive for December, 2008

New Fraxel Web Site Features Before and After Photos

Monday, December 29th, 2008

Reliant Technologies has completed development of an innovative new website for Fraxel, the fractional laser technology designed for skin resurfacing and rejuvenation.

The purpose of the site, according to a company spokesperson, is to educate patients and physicians
on the product and provide “credible information on what makes Fraxel the gold standard in skin rejuvenation.”

Within an impressive flash-animation layout, the new site features recent clinical data, patient educational materials, videos/product demonstrations and an easier ability to compare each Fraxel systems’ intensity level and expected results.

For physicians the site includes web-seminars,video lectures, links to peer-reviewed
articles and clinical studies featuring the Fraxel laser.

Dr. Carney offers Fraxel laser treatment at Skin Speaks Medical Spa in Burnsville.

As Demand For Dermal Fillers Increases – FDA Reviews Labeling, Complications

Saturday, December 13th, 2008

On November 18, 2008, the US Food and Drug Administration convened a panel of outside experts to review the various complications that have been associated with cosmetic dermal fillers like Juvederm, Restylane, Radiesse and others that continue to flood the market. They discussed the possibility of labeling changes, because over the last six years, the FDA has received about 900 reports about complications related to injectable wrinkle-fillers.  Is this a reason to worry?

It might sound alarming, but the complications and side effects associated with these products are still extremely rare.  Demand for fillers and Botox has exploded in recent years, leading many inadequately trained persons to administer them in non-medical settings.

The vast majority of industry professionals will attribute the reported complications to issues like these.  There are also well known complications that occur, like minor swelling or allergic reactions, with the latter being a subject of greater FDA interest.

According to a recent MSNBC news article, Allergan spokeswoman Caroline Van Hove said “no serious problems were seen in clinical trials of Juvederm, and the most common complaint since its approval was swelling in 0.4 percent of patients.”  Also, Food and Drug Administration officials noted that the “reports had several limitations such as failing to say when the problems started.”

Safety and proper training is of the utmost importance with almost any cosmetic procedure, so we recommend that all patients seek a knowledgeable physician with the right qualifications.

For more information on the FDA panel discussion, the briefing is located here.

Johnson and Johnson Acquires Mentor, PurTox Looms on Horizon

Saturday, December 13th, 2008

A $1.1 billion dollar deal was announced on December 1 for giant Johnson & Johnson to acquire breast implant and cosmetic specialities supplier, Mentor corporation.  Analysts say that recent market turmoil and the consumer spending slump may have forced the deal.  While breast implant procedures have dropped off significantly in the current market, non-invasive procedures like Botox have maintained strength. which could be good news for both companies.

By late 2010, Mentor (which will stand alone post-acquisition) is expected to receive FDA approval on a new wrinkle-relaxing, injectable neuroxtoxin called PurTox.  The product should place Mentor (and J&J) in direct competition with Botox manufacturer Allergan.